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Safety and efficacy of maintenance ketamine treatment in patients with treatment-refractory generalised anxiety and social anxiety disorders.

Paul Glue, Shona Neehoff, Natalie J. Medlicott, Andrew Gray, Guy Kibby, Neil McNaughton

Journal of Psychopharmacology June 2018 DOI: 10.1177/0269881118762073 (opens in new tab)

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Characteristics Uncontrolled open-label maintenance treatment study Peer reviewed
Sample size 20
Population Patients with treatment-refractory DSM IV generalized anxiety disorder and/or social anxiety disorder; 10 women and 10 men, 15 met criteria for GAD and 18 for SAD
Intervention Ketamine
Dose 1 mg/kg injected subcutaneously, one or two doses weekly
Duration 3 months of weekly ketamine, with post-treatment remission assessment
Measures Fear Questionnaire, Hamilton Anxiety ratings, Clinician Administered Dissociative States Scale
Topics Ketamine Anxiety Esketamine
Keywords Generalised anxiety disorder Maintenance treatment Social anxiety disorder
Key points Weekly ketamine maintenance for 3 months was safe and well tolerated in treatment-refractory GAD/SAD, with Fear Questionnaire and Hamilton Anxiety ratings falling about 50% one hour after dosing and dissociative symptoms tending to decline with repeated dosing (mean 20 points at week 1 to 8.8 at week 14). Eighteen of 20 patients reported improved social and/or work functioning. The authors propose maintenance ketamine may be a therapeutic alternative for this population.

Abstract

In this maintenance treatment study, we sought to evaluate the effect on anxiety ratings, safety and tolerability of 3 months of weekly ketamine in 20 patients with treatment-refractory DSM IV generalised anxiety disorder (GAD) and/or social anxiety disorder (SAD), and subsequent assessment of remission post-treatment. This was an uncontrolled open-label study in 20 patients who had been responders in an ascending dose ketamine study. The study was undertaken in a university clinic. Patients received one or two weekly ketamine doses of 1 mg/kg injected subcutaneously for 3 months. Data were collected from December 2015-June 2017. There were 10 women (50%) and 10 men (50%); 15 patients (75%) met criteria for GAD and 18 (90%) for SAD. One hour after dosing, Fear Questionnaire ratings decreased by ~50%, as did Hamilton Anxiety ratings. Clinician Administered Dissociative States Scale mean scores declined over time, from 20 points at week 1 to 8.8 points at week 14. Compared with pre-dose values, mean systolic and diastolic blood pressure increased by ~10 mm Hg at 30 min. The most common adverse events were nausea, dizziness and blurred vision. Of the 20 patients, 18 reported improved social functioning and/or work functioning during maintenance treatment. Weekly ketamine dosing was safe and well tolerated, and post-dose dissociative symptoms tended to reduce after repeated dosing. Patients reported marked improvements in functionality and in their personal lives. Maintenance ketamine may be a therapeutic alternative for patients with treatment refractory GAD/SAD. http://www.anzctr.org.au/ACTRN12615000617561.

Comparable studies

Other non-randomized and open-label trials on ketamine for anxiety, most cited first.

Study Year Design Participants
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Brain-Derived Neurotrophic Factor and Initial Antidepressant Response to anN-Methyl-D-Aspartate Antagonist Adults aged 18 to 65 years with DSM-IV major depressive disorder (treatment resistant) 2009 Open-label trial n = 23
Effect of Baseline Anxious Depression on Initial and Sustained Antidepressant Response to Ketamine Inpatients with treatment-resistant major depressive disorder 2014 Post hoc analysis of a single-arm open-label trial n = 26
A single infusion of ketamine improves depression scores in patients with anxious bipolar depression Patients with anxious (n=21) and non-anxious (n=15) treatment-resistant bipolar... 2014 Post-hoc analysis of a clinical trial n = 36
Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study Patients with treatment-resistant depression/anxiety who had previously demonstrated... 2020 Open-label flexible dose uncontrolled study n = 7

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